03/07/2024
Dentist? Here's why the new CE MDR matters 👇
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As many of you may already know, European authorities have initiated the transition process from the old Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). This transition entails significant changes in how authorities regulate medical devices and oversee them.
Without delving too deeply into the details, the process involves more comprehensive testing of products and higher quality control standards, essentially urging manufacturers to enhance processes and adhere to stricter regulations. Among other things, this also means higher costs, which may force smaller players out due to a lack of capability or willingness to upgrade.
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So, how does this affect you as a dentist?
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If you're using medical products today (like dental implants, for example), you're obligated to comply with these new regulations. Starting from 2027, using non-MDR approved products will be a criminal offense. If your current supplier/manufacturer has initiated the MDR process, they likely received an extension and have time to complete it. If they haven't begun the process, their products may exit the market, and they might cease operations in Europe (or altogether). It's your professional and ethical obligation to ensure your manufacturer complies with these standards or at least is progressing towards them so you're not left in a precarious situation when the time comes.
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Of course, if the company you work with is well-known and reputable, chances are you have nothing to worry about, and everything is in order. However, if you're dealing with a smaller/medium-sized company, I strongly advise you to communicate with the manufacturer and get answers.
Based on our extensive experience in the industry, we highly recommend verifying information with the notified body and ensuring that current approvals are valid and that the MDR process has indeed commenced.
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If you don't trust your current manufacturer and are seeking a reliable, long-term partner with MDR approvals to work with, send us a message and let’s talk!
